There are about 21062 clinical studies being (or have been) conducted in Italy. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
Observational study. Participants of the FRASNET study (9th March 2017, Protocol No. 24/INT/2017) who were evaluated in 2016 and 2017 will be contacted to be re-evaluated with multidimensional visits as part of the present study in order to assess trajectories and biomarkers of frailty and sarcopenia. Moreover, are going to evaluate with the same multidimensional visits patients with mild cognitive impairment and dementia followed up at the Neurologic Unit of the San Raffaele Hospital.
Differential diagnosis between Unresponsive Wakefulness Syndrome (UWS) and Minimally Conscious State (MCS) is complicated due to severe cognitive and/or sensorimotor deficits in these patients. In this study the investigators aimed at exploring the diagnostic and prognostic validity of spontaneous eye blinking parameters (rate, amplitude, duration, variability) in a sample of patients with Disorders of Consciousness (DoC). This is a multi-center prospective observational study conducted in patients with Severe Acquired Brain Injury (sABI) and DoC admitted to 8 European participating centers, with clinical data collection not deviating from routine practice. The study is non-commercial and will have a maximum total duration of 24 months.
The study is mixed-methods (qualitative + quantitative observational cross-sectional) and the aims are to explore the use of diaries by parents of newborns admitted to Neonatal Pathology and to describe some variables related to their experience during their children's hospitalization, such as: stress level, postpartum depression and perceived support. The diary that will be analyzed is already part of current clinical practice. Study population: - Parents of premature infants with gestational age less than or equal to 35 weeks and infants with birth weight less than or equal to 2kg admitted to Neonatal Pathology of San Raffaele Hospital. - Health workers of the O.U. of Neonatal Pathology.
Mediterranean diet is worldwide promoted as one of the healthiest and most sustainable dietary patterns. One of the main pillars of Mediterranean diet is the abundant consumption of plant-based ingredients typically consumed as raw or minimally processed. However, even in the Mediterranean countries, these fresh foods are increasingly replaced by ultra-processed foods (UPF). Epidemiological evidence suggests that consumption of UPF may be detrimental to human health, but there is only one clinical trial on this topic which is largely debated in the scientific community due to limitations related to the short duration of the trial and the composition of dietary interventions. The present study aims at exploring whether the inclusion of UPF within a Mediterranean-based dietary pattern can impact on cardiometabolic markers, gut microbiota and other health markers in a dietary intervention performed in Italian subjects. For this purpose, 50 clinically healthy subjects will be recruited for a 7-month randomized, open, cross-over dietary trial. Eligible participants will be randomly assigned to consume a 3-month Mediterranean diet high in UPF (intervention group) or a low-UPF Mediterranean diet (control group), spaced by a 1-month wash-out period. The two diets will have the same composition in terms of food groups. However, in the high-UPF Mediterranean diet group, 5 servings/day of UPF, as defined by the NOVA system, will be consumed (e.g., flavored yogurt, breakfast cereals with added sugar, processed meat). In the control group, these foods will be replaced by products from the same food group, but not UPF (e.g., plain yogurt, breakfast cereals with no added sugar, unprocessed meat). The inflammatory potential of pairs of food products, both UPF and non UPF, will be evaluated using an in vitro cell model testing the modulation of inflammatory markers. Before and after each intervention blood, urine and fecal samples will be collected. The primary endpoint is change in low-density lipoprotein (LDL) cholesterol levels from baseline. Among the other markers, blood pressure and anthropometric parameters will be measured; biochemical parameters, adipokines, inflammatory and oxidative stress markers, fecal microbiota composition and short chain fatty acids (SCFAs) will be analyzed. Adherence to the study, dietary intake and food waste production will be evaluated through specific food diaries, useful also for estimating the metabolic food waste.
In recent decades, the prevalence of obesity and overweight has dramatically increased globally, representing a serious problem for society and for the health system of many countries, estimating an impact of 2-8% on global health spending. Obesity and overweight represent a problem not only for adults but also for children and adolescents: the latest data from the WHO estimate that about 340 million children and adolescents between 5 and 19 years are overweight or obese, data that increase drastically since 1975 from 4% of boys to 18% in 2016. (World Health Organization (WHO). The reduction and prevention of overweight and obesity in childhood is one of the main missions of public health at the global level, both for short-term and long-term implications. Recently, the importance of bioprothesiometric analysis (BIA) in the clinical routine has been evaluated, as it allows an estimation of body composition that would not otherwise be provided by the growth curves and the calculation of the Body Mass Index (BMI). In this study the investigators want to evaluate, in addition to the classic clinical parameters, the body composition of patients evaluated by means of an impedance balance (named TANITA MC780 MA P). With this study the investigators aim to investigate possible clinical and body composition changes in children and adolescents suffering from overweight and obesity with the ultimate aim of reducing cardio-metabolic risk factors related to it. The objective of the study is the assessment of body composition, as an indicator of accuracy of lean mass, but especially of fat mass, of pediatric patients who are overweight and obesity in order to carry out a more complete evaluation of the clinical-metabolic condition for the prevention of cardiovascular risk. The secondary objective is to assess the dietary compliance of the patients being studied and the possible correlation with the body composition.
This is an experimental study without drug or device, randomized, open-label, non-profit, sponsored by the IRCCS Sacro Cuore Don Calabria Hospital in Negrar, which will take place at the Department of Advanced Oncological Radiotherapy and 18 other Italian centers. The reason for this research study is to evaluate whether stereotactic radiotherapy treatment (SABR), in addition to the systemic chemotherapy treatment foreseen by clinical practice for low-intermediate risk oligometastatic colorectal cancer, is able to: - delay possible local recurrence and/or distant polymetastatic progression - improve disease-free survival - reduce side effects in the short and long term thus inducing an improvement in the quality of life of patients suffering from this type of pathology. Therefore, as part of this randomized study, before starting first or second line systemic therapy for his tumor, the patient will be randomized to one of the following treatment arms: - Experimental arm: ablative stereotactic radiotherapy on all sites of oligometastatic disease (from 1 to 3 sites, performed at most within the second cycle of systemic therapy) - Control arm: no ablative stereotactic radiotherapy to sites of oligometastatic disease The procedure that is intended to be tested in the experimental arm is a stereotactic radiotherapy treatment on oligometastases (up to a maximum of 3 sites), with ablative dosage (effective biological dose >100 Gy), performed before the start of systemic therapy of I or II line (at most within the second cycle of the same). It is hoped that the addition of this type of radiotherapy will increase the potential clinical benefit of the treatment in the context of colorectal cancer.
Patients with heart failure and a preserved left ventricular ejection fraction (HFpEF) almost invariably complain of exertional breathlessness. Abnormal cardiac hemodynamics with pulmonary congestion are believed to trigger dyspnea in this patients. However, some patients may complain of exertional breathlessness which seems to be out of proportion as compared with hemodynamic abnormalities. Chemoreflex sensitivity accounts for the ventilatory responses to a variety of chemical stimuli, including carbon dioxide produced by the organism during exercise. Chemoreflex sensitivity can be augmented in heart failure with reduced left ventricular ejection fraction, and an increased chemoreflex sensitivity has been linked to symptoms, neurohumoral activation, breathing disturbances, and adverse prognosis. However, the clinical correlates and implications of chemoreflex sensitivity in HFpEF have not been accurately studied. We aim to characterize chemoreflex sensitivity in patients with a diagnosis of HFpEF, and to correlate chemoreflex sensitivity with clinical and hemodynamic characteristics.
Evaluation of the performance of an in vitro test, the STANDARDTM F TB LAM Ag FIA (SD BIOSENSOR, INC.) for the early diagnosis of tuberculosis (TB) infection. This test is for in vitro professional diagnostic use and intended as an aid to early diagnosis of tuberculosis infection. The test will be used according to the instructions for use (IFU).
The project aims to implement the Internet Of Thing (IoT) platform of the San Raffaele Hospital (OSR) with data from stress conditions perceived by the patient through the synergistic collaboration between patients, gastroenterologists and psychologists.
Chronic pain (CP) is a leading cause of medical disability, healthcare expenditure, and reduced psychological well-being. Given the limited mobility, travel burden, and cost, access to care can be problematic for patients suffering from this disease, driving the recent shift toward care through telehealth programs. Given the complex interrelationship of physical and psychosocial aspects related to chronic pain, in this project the investigators propose to validate and investigate the effectiveness of new integrated health interventions by combining the technique of transcranial direct current stimulation (tDCS), complementary therapies and telemonitoring. The investigators hypothesize that this novel combined approach will provide a more effective strategy to overcome the classic barriers of pharmacological treatments and access to healthcare due to lack of mobility. To do this, the investigators will rely on a previously developed integrated platform that enables effective delivery of non-pharmacological interventions and outcome assessment. Many patients do not benefit from pharmacological and invasive treatments, leading to the development of alternative therapeutic options such as non-invasive brain stimulation (e.g. tDCS) and complementary interventions to improve physical and psychological well-being. These complementary interventions reduced pain intensity and psychological distress by improving individuals' ability to manage and cope with their pain. However, due to the multiple co-occurring factors associated with chronic pain, a multidisciplinary and integrated treatment approach is challenging. Technology ecosystems can be a reliable tool to achieve such a diverse personalized approach and evaluate their results. In a previous project, the investigators developed PainRE-Life, a dynamic and integrated technology ecosystem to enable continuity of care for CP patients, including personalized applications, training tools and telemonitoring tools for outcome assessment.